Tagged as: IPR

This morning, the Federal Circuit issued its much anticipated decision in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals. A panel of the court, consisting of Judges Dyk, Moore, and Reyna, held that “tribunal sovereign immunity cannot be asserted in IPRs.” Relying on the Supreme Court’s decisions in Oil States and SAS Institute,…

There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in favor of the biosimilar applicants. The other five appeals are from final written decisions of the…

On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require aBLA…

Below are a few recent updates in IPR proceedings concerning biologic-related patents: Today, the Board denied Samsung Bioepis’ petition for IPR of Genentech’s U.S. Patent No. 7,846,441 (IPR2017-00192), directed to cancer treatment methods using trastuzumab. In its decision, the Board explained that it was exercising its discretion to deny the petition in…

On November 11, 2017, Pfizer, Inc. filed a petition for inter partes review (IPR) of Biogen and Genentech’s US Patent No. 8,545,843, which relates to a method of treating vasculitis with rituximab. (IPR2018-00086.) On May 31, 2018, the PTAB denied institution of this IPR. Separately, on June 4, 2018, Pfizer filed…

Today, the PTO announced proposed rulemaking to change the claim construction standard applied by the PTAB in IPR, PGR, and CBM proceedings. In particular, the PTO proposes replacing the broadest reasonable interpretation standard for construing unexpired patent claims with the standard applied in federal district courts and ITC proceedings as…

As we reported earlier this week, the Supreme Court held in SAS Institute Inc. v. Iancu that when the PTAB institutes an IPR, it must decide the patentability of all challenged claims. The U.S. Patent and Trademark Office yesterday issued guidance on the impact of SAS. The guidance explains that going forward: …

Last week, the Patent Trial and Appeal Board (“Board”) instituted inter partes review of two patents directed to methods of administering adalimumab for the treatment of psoriasis, based on petitions filed by Sandoz: IPR2017-02105 (challenging U.S. Pat. No. 9,090,689) and IPR2017-02106 (challenging U.S. Pat. No. 9,067,992). Separately, the Board issued…

Last week, in the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, Immunex moved to stay the litigation pending resolution of two IPR proceedings the PTAB instituted on February 15, 2018 (IPR2017-01879 and IPR2017-01884) regarding the sole asserted patent: U.S. Patent No. 8,679,487….

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